MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC.; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Nerve Damage (1979); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Medtronic is submitting this report to comply with fda reporting if information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician did a back surgery which involved posterolateral fusion from l4 to l5 with segmental pedicle screw fixation bilaterally.But they used the wrong size screw(used of 6.5 cm length screw instead of 6.0 cm length screw).As a result of this, the longer screw was in contact with the nerve which was causing significant neural irritation and injuries.The patient suffered from pain, nerve damaged, physical and emotional trauma.On (b)(6) 2017, ct lumbar was performed at that she was told that screw was affecting her nerve.

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 85281
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 85281
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8815286
• MDR Text Key: 151840580
• Report Number: 1030489-2019-00801
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other